Largest-ever Prevention Trial on Prostate Cancer Enters Second Year of Recruitment

Monday, October 14, 2002

ROCHESTER, Minn. - Mayo Clinic continues to successfully enroll men in the largest-ever prostate cancer prevention clinical trial, known as SELECT. SELECT, which stands for the Selenium and Vitamin E Cancer Prevention Trial, will ultimately enroll 32,400 men at 435 centers across the United States and Canada and in Puerto Rico. Researchers hope to enroll all the participants for this trial during the next four years. Launched in July 2001, SELECT, sponsored by the National Cancer Institute (NCI), seeks to enroll healthy men aged 55 or older (aged 50 or older for African-Americans). This trial is attempting to determine if either selenium or vitamin E can protect against prostate cancer, the most common form of cancer, after skin cancer, in men. Mayo Clinic is part of a network of research sites that collectively reached 43 percent of the trial's recruitment goal during the first year.

"In the 12 months since the launch, we have worked to educate men and their families in Southeastern Minnesota about prostate cancer and the potential benefits of participating in this study," said Michael Lieber, M.D., a Mayo Clinic oncologist and principal investigator. "In this next year, we will continue to talk to men about their prostate cancer risk and ask them if they are willing to help us learn whether the effects of selenium and vitamin E, both separately and together, can prevent the disease."

Previous research involving selenium and vitamin E for other cancers suggested these nutrients might reduce the risk of prostate cancer. Selenium and vitamin E, both naturally occurring nutrients, are antioxidants. The only definitive way to determine the real value of these supplements in preventing the development of prostate cancer is through a large clinical trial like SELECT.

During 2002, prostate cancer will be diagnosed in about 189,000 Americans, and more than 30,200 men are expected to die of the disease. In Minnesota, 3,600 men will get prostate cancer, and 600 men will die of it. Risk factors for the disease include being over age 55, being African-American or having a father or brother with prostate cancer.

Of the 13,951 men currently enrolled in SELECT, 1,619 (11 percent) are African-American. Because African-American men are at a greater risk of developing prostate cancer, they are eligible to join SELECT beginning at age 50 (compared with age 55 for other racial and ethnic groups).

"We are obviously quite pleased with the enormous success in the first year," said Leslie G. Ford, M.D., who is associate director for clinical research in NCI's Division of Cancer Prevention and is overseeing SELECT for NCI. "In this next year, we will place increased emphasis on reaching out to African-American men and asking them to consider enrolling in SELECT. It is crucial that men of all races and ethnic backgrounds participate in SELECT," Dr. Ford added. African-American men in the United States have the highest rate of prostate cancer in the world.

Men in the study from Southeastern Minnesota will visit Mayo Clinic once every six months. Upon enrollment, they will be assigned by chance to one of four groups. One group will take 200 micrograms of selenium daily plus an inactive capsule, or placebo, that looks like vitamin E. Another group will take 400 milligrams of vitamin E daily along with a placebo that looks like selenium. A third group will take both selenium and vitamin E. And a final group will be given two placebos.

Men who join SELECT will not need to change their diet in any way, but they must stop taking any supplements they buy themselves that contain selenium or vitamin E. If participants wish to take a multivitamin, a specially formulated, free multivitamin will be provided through SELECT that does not contain selenium or vitamin E.

Men may be able to participate in SELECT if they:

• Are aged 55 or older; aged 50 or older for African-American men
• Have never had prostate cancer and have not had any other cancer, except non-melanoma skin cancer, in the last five years
• Are generally in good health

Men interested in joining the study can call Mayo Clinic's Urology Clinical Research Unit at 507-284-3369. For more information about the study or prostate cancer:

• In the United States (including Puerto Rico), call the National Cancer Institute's Cancer Information Service at 800-4-CANCER (800-422-6237) for information in English or Spanish. The number for callers with TTY equipment is 800-332-8615.
• In Canada, call the Canadian Cancer Society's Cancer Information Service at 888-939-3333 for information in English or French.
• Visit NCI's Web site at http://cancer.gov/select or visit Southwest Oncology Group's Web site at http://swog.org and choose SELECT.

Contact:
Richard D. Hurt, Jr.
507-284-5005 (days)
507-284-2511 (evenings)
e-mail: newsbureau@mayo.edu

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